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510(k) Data Aggregation

    K Number
    K232824
    Device Name
    FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
    Manufacturer
    Owens & Minor (O&M) Halyard, Inc.
    Date Cleared
    2024-07-02

    (293 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K110455
    Why did this record match?
    Reference Devices :

    K110455

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.

    Device Description

    The subject device(s) are ASTM F2100 Level 1 (white in color) Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Mask(s) are provided with earloops. A malleable nosepiece is placed within the bindings. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family will be provided in designs with and without a protective visor. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single use, disposable devices, provided non-sterile.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance:

    PurposeTestAcceptance CriteriaReported Device Performance (Result)
    Face Mask PerformanceASTM F2100ASTM F2100 Level 1Pass
    Bacterial Filtration EfficiencyASTM F2101≥95%Pass
    Particulate Filtration EfficiencyASTM F2299≥95%Pass
    Differential PressureEN 14683
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